Efficacy and safety of ivermectin and albendazole co-administration in school-aged children and adults infected with Trichuris trichiura: study protocol for a multi-country randomized controlled double-blind trial

Abstract

BackgroundSoil-transmitted helminthiasis affects almost 2 billion people worldwide in tropical climates. Preventive chemotherapy, using the benzimidazoles (albendazole and mebendazole) is the current main recommended control strategy. Nevertheless, there is limited efficacy of these drugs against hookworm infection and, to a greater extent, against trichuriasis. We describe a protocol for a trial investigating the efficacy and safety of the co-administration of ivermectin and albendazole against trichuriasis.MethodsA double-blind, placebo-controlled randomized controlled trial will be conducted in three countries (Côte d’Ivoire, Tanzania and Lao PDR) with the aim to determine the efficacy, safety and extended effects of co-administered ivermectin and albendazole compared to standard albendazole monotherapy. We will enroll 600 participants aged 6–60 years in each setting. The primary outcome is cure rate (CR) against Trichuris trichiura infection as assessed by Kato-Katz 14–21 days after treatment. Secondary outcomes include CRs against concomitant soil-transmitted helminth (STH) infections (Ascaris lumbricoides, hookworm and Strongyloides stercoralis) and egg reduction rates (ERRs) against STH at 14–21 days, 180 days and 360 days. Tolerability of treatment, infection status assessed by polymerase chain reaction (PCR), and potential benefits of deworming on nutritional and morbidity indicators will be assessed. The primary analysis will include an available-case set and use logistic regression models adjusted for age, sex and weight.DiscussionThis trial will provide robust results on the efficacy and safety of co-administration of ivermectin and albendazole with the aim to better inform WHO recommendations on control of STHs. Furthermore, secondary and explanatory outcomes will provide direct evidence on the extended effects of combination therapy and insight on the relationship between nutrition and morbidity parameters and infection status and intensity.Trial registrationNCT03527732 (date assigned: 17 May 2018).Electronic supplementary materialThe online version of this article (10.1186/s12879-019-3882-x) contains supplementary material, which is available to authorized users.

Performance of the Kato-Katz method and real time polymerase chain reaction for the diagnosis of soil-transmitted helminthiasis in the framework of a randomised controlled trial: treatment efficacy and day-to-day variation

“…Trial details are summarized in the published trial protocol [37] and in the trial registration (clinicaltrials.gov, reference: NCT03527732, date assigned: 17 May 2018). Participants were invited for clinical examination and treatment if found positive for T. trichiura infection in at least two slides of quadruple Kato-Katz thick smears with an infection intensity of at least 100 eggs per gram (EPG) of stool.…”

Long-term outcomes of ivermectin-albendazole versus albendazole alone against soil-transmitted helminths: Results from randomized controlled trials in Lao PDR and Pemba Island, Tanzania

“…Consenting participants were eligible for the trial if they had provided two fecal samples at baseline, were aged between six and 60 years, weighed at least 15 kg, were positive for T. trichiura infection in at least two slides of the quadruple Kato-Katz smears and had an infection intensity of at least 100 eggs per gram (EPG) of stool. After an initial clinical examination, participants were excluded if they were pregnant or lactating in the 1 st week after birth, had a major systemic illness, had clinical malaria, had a history of severe acute or chronic diseases, or met other exclusion criteria listed in the trial protocol [22].…”

Single-dose Albendazole 400 mg Effectiveness in <i>Ascaris lumbricoides</i> and <i>Trichuris trichiura </i>Infections

“…More than 5 billion people in the world run the risk of being infected with Soil-Transmitted Helminth (1). At present, it is estimated that more than 2 billion people are infected (2,3). Generally, it comes from poor people in developing countries (3,4), the majority in pre-school children and in school-age children in Asia, Africa and Latin America (2,4).…”

“…Soil-Transmitted Helminthiasis is caused by nematode worm infection (5), namely Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and Necator americanus or Ancylostoma duodenale (hookworm) (2,4,6,7).…”

“…Infection occurs through contamination of food containing infective eggs Trichuris trichiura and Ascaris lumbricoides or through skin penetration by hookworm larvae (2). Hookworm infection is more common in adults (4).…”